Severity of harm or risk is classified into three levels, each of which includes a duration
component. The three levels are medical device-related deaths or serious injuries, medical
device-related non-serious adverse events, and medical device-related events without reported
harm.
Medical device-related deaths and serious injuries include those events (including
procedure related complications) that may have been or were attributed to the use of the
medical device and that cause or contribute to a death or injury or illness that is life threatening,
results in permanent impairment or damage to the body, or requires medical or
surgical intervention to prevent permanent harm to the body.
Medical device-related non-serious adverse events include those events (including procedure related complications) that may have been or were attributed to the use of the medical device and that cause or contribute to minor, temporary or medically reversible injuries that do not meet the criteria for classification as a medical device-related serious injury.
Medical device-related events without reported harm include medical device
non-conformities which have no related harm, medical device malfunctions which have no
related harm, procedure related complications with no related harm, and instances where a
nonconformity or regulatory noncompliance was observed at the medical device
manufacturing facility and no defective devices were released to the market. A medical
device nonconformity or malfunction can include the failure of a medical device to meet
its performance specifications even though the device still performs adequately to meet the
needs of a given patient.